What changed in this filing

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Item 1. Business

2026-03-10 compared with 2025-03-13 · 74 added, 47 removed, 235 unchanged (34% of the section changed)

Apyx Medical Corporation (“Company”, “Apyx Medical”, “we”, “us”, or “our”) was incorporated in 1982, under the laws of the State of Delaware and has its principal executive office at 5115 Ulmerton Road, Clearwater, FL 33760.

We are an advanced energy technology company with a passion for elevating people’s lives through innovative products, including our Helium Plasma Platform Technology products marketed and sold as Renuvion ® in the cosmetic surgery market and J-Plasma ® in the hospital surgical market.

We are a surgical aesthetics company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Platform Technology products marketed and sold as Renuvion ® and the AYON Body Contouring System TM (“AYON”) in the cosmetic surgery market and J-Plasma ® in the hospital surgical market.

Renuvion and J-Plasma offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results.

We also leverage our deep expertise and decades of experience in unique waveforms through Original Equipment Manufacturer (“OEM”) agreements with other medical device manufacturers.

AYON is an FDA-cleared, surgeon-designed body contouring system that combines precision, versatility, and innovation in an all-in-one platform.

It seamlessly integrates fat removal, closed loop contouring, and Renuvion’s tissue contraction and electrosurgical capabilities, empowering surgeons to deliver comprehensive body contouring treatments for patients.

We also leverage our deep expertise and decades of experience in unique waveforms through OEM agreements with other medical device manufacturers.

Recent Business Developments

On January 6, 2025, we announced that we had submitted a 510(k) premarket notification to the FDA for the AYON Body Contouring System ("AYON").

On May 13, 2025, we announced that we had received 510(k) clearance from the U.S.

Food and Drug Administration (the “FDA”) for AYON.

We completed the soft launch of AYON, leveraging our relationships with key surgeons in critical geographies.

Additionally, we commenced the commercial launch of AYON in September 2025.

AYON was developed with a focus on versatility and innovation.

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Renuvion treatment to address loose and lax skin

During 2025, we plan to expand the indications with an additional 510(k) submission for AYON to include power assisted liposuction.

On October 13, 2025, we announced that we had submitted the 510(k) premarket notification to the FDA for the label expansion of AYON to include power liposuction.

We anticipate receiving clearance in the second quarter 2026.

On July 28, 2025, we announced the launch of Renuvion in China following receipt of initial market clearance from the National Medical Products Administration of China.

We have incurred recurring net losses and cash outflows from operations and we anticipate that losses will continue in the near term.

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workforce by nearly 25%.

We estimate the annualized future cost savings from the reduction in force to be approximately $4.3 million, which we expect to contribute to our goal of decreasing losses and achieving cash-flow breakeven.

We estimated the annualized future cost savings from the reduction in force to be approximately $4.3 million.

We incurred pre-tax charges of approximately $0.6 million in the fourth quarter of 2024 representing, for the most part, one-time cash expenditures for severance and other employee termination benefits.

In addition to the reduction in force, we eliminated bonuses in 2024, reduced the size of the board of directors from eight to five members and reduced aggregate board cash compensation from $0.5 million annually to $0.1 million, while increasing board stock-based compensation.

In addition to the organizational changes, we have identified other direct cost savings we anticipate achieving in 2025.

The identified cost savings include reductions in professional fees, lower research and development costs as we complete the development of AYON, lower credit card fees and stock-based compensation.

We foresee, in totality, these cost savings will reduce our annual operating expenses below $40 million in 2025.

In addition to the organizational changes, we identified other direct cost savings we achieved in 2025.

The identified cost savings include reductions in professional fees, lower research and development costs, lower credit card fees and stock-based compensation.

These cost savings reduced our annual operating expenses below $40.0 million in 2025, as compared to $48.2 million and $53.7 million in 2024 and 2023, respectively.

APYX MEDICAL CORPORATION

On November 22, 2022, we filed a shelf registration statement providing us the ability to register and sell our securities in the aggregate amount up to $100 million.

The shelf registration statement included an embedded ATM facility for up to $40 million.

To date we have not utilized this facility.

On November 8, 2023, we entered into a Credit and Guaranty Agreement (the “Perceptive Credit Agreement”), by and among Apyx Medical (as borrower), Apyx China Holding Corp.

and Apyx Bulgaria EOOD, our wholly-owned subsidiaries (as subsidiary guarantors), and Perceptive Credit Holdings IV, LP (as initial lender and administrative agent) (“Perceptive”), and the lenders from time to time party thereto.

The Perceptive Credit Agreement provided for a facility of up to $45 million, consisting of senior secured term loans.

The Perceptive Credit Agreement provided for (i) an initial loan of $37.5 million and (ii) a delayed draw loan of $7.5 million.

Our ability to borrow the delayed draw loan of $7.5 million lapsed on December 31, 2024.

On November 7, 2024, we entered into an amendment to the Perceptive Credit Agreement.

The amendment reduced the financial covenant trailing twelve-month revenue targets relating to its Advanced Energy segment (tested quarterly), with amended year-end targets of $34.4 million, $37.0 million, $52.4 million and $60.3 million for 2024, 2025, 2026 and 2027, respectively.

The amendment reduced the financial covenant trailing twelve-month revenue targets relating to our Surgical Aesthetics segment (tested quarterly), with amended year-end targets of $37.0 million, $52.4 million and $60.3 million for 2025, 2026 and 2027, respectively.

The amendment also introduced a maximum operating expense financial covenant, with full year targets of $40.0 million and $45.0 million for 2025 and 2026, respectively.

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As of December 31, 2025, we were in compliance with the financial covenants contained within the Perceptive Credit Agreement, as amended.

Our continued compliance with covenants is subject to meeting or exceeding forecasted Advanced Energy revenues, as amended, and reducing operating expenses.

Our continued compliance with covenants is subject to meeting or exceeding forecasted Surgical Aesthetics revenues, as amended, and operating expenses targets.

For a more in-depth description of the terms of the Perceptive Credit Agreement, as amended, see Note 10 in Item 8 of this Annual Report on Form 10-K.

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For a more in-depth description of the terms of the registered direct offering, see Note 12 in Item 8 of this Annual Report on Form 10-K.

On November 18, 2025, we entered into an underwriting agreement where we sold 2,762,431 shares of common stock at an offering price of $3.62.

After deducting incremental direct costs of the Offering, the Company’s net proceeds were approximately $9.1 million.

For a more in-depth description of the terms of the offering, see Note 12 in Item 8 of this Annual Report on Form 10-K.

On December 1, 2025, we filed a shelf registration statement providing us the ability to register and sell our securities in the aggregate amount up to $100 million.

This shelf registration statement replaced our previous shelf registration statement that expired during December 2025.

Our direct sales force, along with our international network of distributors, is focused on becoming the sole provider of surgical equipment in the cosmetic surgical markets.

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Apyx Bulgaria, EOOD is a wholly owned limited liability company incorporated under Bulgarian law, located in Sofia, Bulgaria.

It is engaged in the business of development and manufacturing of our advanced energy generators, as well as the manufacturing of our single-use handpieces and accessories, and development and manufacturing of OEM generators and related accessories.

It is engaged in the business of development and manufacturing of our surgical aesthetics generators, AYON equipment, as well as the manufacturing of our single-use handpieces and accessories, and development and manufacturing of OEM generators and related accessories.

The facility also distributes products directly to customers in certain international markets and provides warranty and repair services.

Joint Venture

In 2019, we executed a joint venture agreement with its Chinese supplier whereby we have a 51% ownership interest, to establish a presence in the Chinese market for the manufacturing and sale of our Advanced Energy products.

As of the date of this report, the joint venture has not commenced its principal operations.

The joint venture commenced operations in the second quarter of 2025.

The cosmetic surgery market is a special segment of the medical field, which is involved in the restoration, reconstruction, or alteration of the human body to enhance the body’s appearance.

The market for cosmetic surgery includes surgical, minimally invasive, and nonsurgical cosmetic procedures.

APYX MEDICAL CORPORATION

Glucagon- like peptide -1 peptide receptor agonists (“GLP-1’s”), such as Mounjaro ® , Wegovy ® and Ozempic ® , are prescribed for the treatment of diabetes and or weight loss in combination with exercise to improve glycemic control.

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Studies have shown patients taking GLP-1’s have experienced a loss of body weight.

Currently, two GLP-1’s are cleared by the FDA for weight loss, but we anticipate a number of additional drug candidates will be cleared as well as, oral versions of these injectable medications.

APYX MEDICAL CORPORATION

Currently, two GLP-1’s are cleared by the FDA for weight loss and now oral versions have been approved, and we anticipate a number of additional drug candidates will be approved.

We believe the increased use of GLP-1’s has had an initial negative impact on the revenue for plastic and cosmetic surgeons and created uncertainty in the aesthetic space.

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This market is expected to have steady growth year-over-year and this growth is driven by social and cultural factors such as the influence of social media, societal influence for appearance and beauty, and increasing disposable income.

According to the recent International Society of Aesthetic Plastic Surgery (“ISAPS”) 2023 Global Survey report, while liposuction procedures contracted 2.9% year-over-year, it continues to be the number one aesthetic surgical procedure globally and all surgical procedures increased 5.5% year-over-year.

Currently, the majority of procedures utilizing our Renuvion technology occur in conjunction with liposuction procedures.

According to the recent International Society of Aesthetic Plastic Surgery (“ISAPS”) 2024 Global Survey report, while liposuction procedures in the U.S.

contracted approximately 10% year-over-year, it continues to be in the top two aesthetic surgical procedure globally and, as a result of the impact of the GLP-1’s on loose and lax skin, surgical lifts have increased greater than 20%.

We believe, as the leader in surgical aesthetics, that we have sustainable, competitive advantages in the cosmetic surgery market for several reasons:

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Our purchase order commitments are never more than one year in duration and are supported by our sales forecasts.

To our knowledge, none of the products that we source are through entities manufacturing in the Xinjiang province.

In response to the global supply chain instability and inflationary cost increases, we continue to take action to minimize, as much as possible, any potential adverse impacts by working closely with our suppliers to closely monitor the availability of raw material components (i.e.

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Accordingly, the significance of the future impact to our business and financial statements remains subject to significant uncertainty.

The value of unshipped factory orders is not material.

APYX MEDICAL CORPORATION

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Our reportable segments are principally organized, managed and disclosed as two operating segments:

Advanced Energy and OEM.

Surgical Aesthetics and OEM.

“Corporate & Other” includes certain unallocated corporate and administrative costs which are not specifically attributed to any reportable segment.

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Asset information is not reviewed by the chief operating decision maker by segment and is not available by segment and, accordingly, we have not presented a measure of assets by reportable segment.

For the year ended December 31, 2024, our Advanced Energy segment contributed 80.3% of our consolidated total revenue and our OEM segment contributed 19.7% of our consolidated total revenue.

Advanced Energy Segment

For the year ended December 31, 2025, our Surgical Aesthetics segment contributed 85.8% of our consolidated total revenue and our OEM segment contributed 14.2% of our consolidated total revenue.

Surgical Aesthetics Segment

Our product portfolio consists of our Helium Plasma Technology that is marketed and sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market.

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In addition, we have invested in training programs and marketing-related activities to support accelerated adoption of our technology into surgeons' practices.

On July 28, 2025, we announced the launch of Renuvion in China following receipt of initial market clearance from the National Medical Products Administration of China.

We launched numerous new extensions to our Helium Plasma product lines in an effort to target new surgical procedures, users, and markets.

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APYX MEDICAL CORPORATION

On January 6, 2025, we announced that we had submitted a 510(k) premarket notification to the FDA for AYON.

On May 13, 2025, we announced that we had received 510(k) clearance from the U.S.

Food and Drug Administration (the “FDA”) for AYON.

We completed the soft launch of AYON, leveraging our relationships with key surgeons in critical geographies.

Additionally, we commenced the commercial launch of AYON in September 2025.

AYON was developed with a focus on versatility and innovation.

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Renuvion treatment to address loose and lax skin

During 2025, we plan to expand the indications with an additional 510(k) submission for AYON to include power assisted liposuction.

On October 13, 2025, we announced that we had submitted the 510(k) premarket notification to the FDA for the label expansion of AYON to include power liposuction.

We anticipate receiving clearance in the second quarter 2026.

In order to assist us in leveraging our Helium Plasma Technology’s precision and effectiveness in multiple surgical specialties, we continue to utilize our Medical Advisory Board, which currently consists of 5 members representing the plastic surgery, facial plastic surgery, and cosmetic procedure specialties.

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While we believe that these investments have the potential to generate additional revenues and profits in the future, there can be no assurance that our Helium Plasma Technology will continue to be successful or that such future revenues and profitability will be realized.

In the U.S., we primarily sell our Renuvion products through our direct sales force to physicians, cosmetic surgery offices and surgical centers.

In the U.S., we primarily sell our Renuvion and AYON products through our direct sales force to physicians, cosmetic surgery offices and surgical centers.

Outside of the U.S., our products are sold primarily through our distributor network.

Our Advanced Energy Products consist of our Helium Plasma Technology lines (Renuvion and J-Plasma).

Our Surgical Aesthetics Products consist of our Helium Plasma Technology lines (Renuvion and J-Plasma).

These product lines consist of a multifunction generator, a handpiece and a supply of helium gas.

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in the fourth quarter of 2022, full commercial launch of the generator in the U.S.

and select international markets started in 2023 and continued in 2024.

and select international markets started in 2023 and continued through 2025.

We continued the sales of our Renuvion System 3 generator, to markets outside the U.S.

and began introducing the Apyx Once Console in markets where we have received regulatory approval.

and began introducing the Apyx One Console in markets where we have received regulatory approval.

Our high frequency electrosurgical generators can be used for delivery of RF energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and minimally invasive surgical procedures.

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During 2021, we began to launch these new handpieces in our international markets, designed specifically for minimally invasive use, with improved ergonomics and safety features.

AYON Body Contouring System

AYON is an FDA-cleared device that provides the surgeon with an all-in-one system to perform any surgical procedure needed in their offices or surgical suite.

The core of the system is our Apyx One Console for the treatment of loose and lax skin and integrates infiltration, aspiration, suction assisted liposuction, ultrasound assisted liposuction, a closed loop for at transfer and electrosurgical capabilities.

In addition, it streamlines surgical procedures, reducing procedure time and improving overall workflow and efficiency.

To replicate the functionality of AYON, the surgeon would need to purchase five separate systems and we can deliver AYON at a competitive cost to the physician.

On May 13, 2025, we announced we had received 510(k) clearance from the FDA for AYON.

We completed our soft launch of AYON, leveraging its relationships with key surgeons in critical geographies.

Additionally, we commenced the commercial launch of AYON in September 2025.

On October 13, 2025, we announced that we had submitted the 510(k) premarket notification to the FDA for the label expansion of AYON to include power liposuction.

We anticipate receiving clearance in the second quarter 2026.

Currently, we are the only company with helium-based plasma products and four specific indications from the FDA.

While the FDA Safety Communication did impact our sales, and we face competition from RF-based, argon plasma, and CO2 laser products within our target market, we still believe our competitive position did not change in 2024.

We believe our focus on the surgical aesthetic market provides us a competitive advantage over noninvasive products due to surgical treatments providing patients with more transformative and durable results.

With the launch of AYON, we now compete directly with companies that have devices that perform liposuction procedures.

The major liposuction manufacturers are Solta Medical (owned by Bausch Health Companies, Inc.) and MicroAire Surgical Instruments.

FDA and Other Government Regulations

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The new medical device regulatory framework and the new privacy regulations in Europe and in other countries are examples of such increased regulation.

For example, the European Union enacted the European Union Medical Device Regulation in May 2017 with an effective date of May 2021, which imposes stricter requirements for the marketing and sale of medical devices, including in the areas of clinical evaluation requirements, quality systems, labeling and post-market surveillance.

Additionally, as a result of the exit of the United Kingdom from the European Union (Brexit), new medical device regulations were released by the United Kingdom, which became effective January 1, 2021.

A gap analysis against the prior Medical Device Directive (“MDD”), a compliance plan was implemented, and the plan is being executed for both the European Union and United Kingdom regulations to ensure compliance and minimize business disruption.

The regulatory agencies under whose purview the Company operates have administrative powers that may subject it to actions such as product withdrawals, recalls, seizure of products and other civil and criminal sanctions.

In some cases, the Company may deem it advisable to initiate product recalls.

For example, the European Union enacted the Medical Device Regulation (EU) 2017/745, or EU MDR, in May 2017, with full application beginning in May 2021.

The EU MDR imposes more stringent requirements for the design, manufacture, clinical evaluation, certification, labeling and post-market surveillance of medical devices marketed in the European Union.

Compliance with these requirements has increased, and may continue to increase, the time and cost required to obtain regulatory approvals and maintain compliance for our products.

In addition, following the United Kingdom’s withdrawal from the European Union, the United Kingdom implemented changes to its medical device regulatory framework effective January 1, 2021.

These changes include the introduction of the UK Conformity Assessed (UKCA) marking and additional device registration requirements with the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) for devices marketed in Great Britain.

A gap analysis was conducted against the prior Medical Device Directive (“MDD”), a compliance plan was implemented, and the plan is being executed for both the European Union and United Kingdom regulations to ensure compliance and minimize business disruption.

The regulatory agencies under whose purview we operate have administrative powers that may subject it to actions such as product withdrawals, recalls, seizure of products and other civil and criminal sanctions.

In some cases, we may deem it advisable to initiate product recalls.

The FDA and regulatory agencies around the globe are also increasing their enforcement activities.

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Equivalent enforcement mechanisms exist in different countries in which we conduct business.

On March 14, 2022, the FDA posted a Safety Communication that warns consumers and health care providers against the use of our Advanced Energy products outside of their FDA-cleared indications for general use in cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

Following the Safety Communication, we experienced slowed demand for the adoption of our Helium Plasma Technology.

Throughout 2022, and continuing into 2023, we worked closely with the FDA to gain clearances for the use of our products in various surgical applications, demonstrating our commitment to both safety and efficacy, supported by both clinical study and real-world data.

APYX MEDICAL CORPORATION

On May 10, 2023, the FDA updated the Safety Communication to inform consumers and healthcare providers about the clearance for the Renuvion APR handpiece for the coagulation of subcutaneous soft tissues following liposuction.

On June 14, 2023, we announced that we received 510(k) clearance from the FDA for the Renuvion Micro handpiece, a new addition to the Renuvion production family.

The Renuvion Micro handpiece was cleared with an indication for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed.

Soft tissue includes subcutaneous tissue.

The costs of human healthcare have been and continue to be a subject of study, investigation and regulation by governmental agencies and legislative bodies around the world.

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Today the regulatory authority members include the US, Australia, Brazil, Canada and Japan, official observers European Union and United Kingdom, and affiliates Argentina, Israel, South Korea, and Singapore.

In February 2022, we underwent a successful annual MDSAP audit by our registrar GMED SAS.

There were no observations related to safety or efficacy of our products noted during this MDSAP audit.

In January 2026, we underwent successful annual MDSAP audits of both our Clearwater and Bulgaria facilities by our registrar GMED SAS.

There were no observations related to safety or efficacy of our products noted during these MDSAP audits.

The FDA accepts MDSAP audit reports as a substitute for routine Agency inspections.

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Revenue, costs and expenses resulting from this agreement are reported in our Consolidated Statements of Operations as a component of income or loss from operations of our OEM reporting segment.

We have been focusing our sales and marketing efforts in the Surgical Aesthetics segment due to the overall size of that market and margins.

Due to our reputation in the space, we will receive inquiries for specialty products opportunistically.

With the focus on Surgical Aesthetics, we anticipate that the OEM segment revenue will decrease over time.

APYX MEDICAL CORPORATION

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business